AGC REVISION KNEE PROTHESIS— 510(k) K912245

Name: FDA 510(k) clearance K912245
Creator: U.S. Food and Drug Administration
Published: 1991-08-19

Substantially Equivalent for Some Indications

Biomet, Inc.

FDA 510(k) clearance K912245 for AGC REVISION KNEE PROTHESIS, Substantially Equivalent for Some Indications on 1991-08-19. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1991-05-21
Decision date: 1991-08-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

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K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
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Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K912245

K-number listed on FDA's recall record

Z-0627-2021 — RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer.Class II·Terminated·Biomet, Inc.·20201125
Z-1086-2019 — Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implantClass II·Terminated·Zimmer Biomet, Inc.·20190301
Z-1087-2019 — Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implantClass II·Terminated·Zimmer Biomet, Inc.·20190301

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K912245.

Data sourced from openFDA. This site is unofficial and independent of the FDA.